Opportunistic Gastric Cancer Screening

Gastric Cancer Clinical Trial

— ROCGAS  

Official title:

ROCGAS - Opportunistic Gastric Cancer Screening

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06316882
• Other study ID #: ROCGAS 01
• Secondary ID: ROGCAS Study
• Status: Recruiting
• Phase: N/A
• Start date: February 3, 2023
• Est. completion date: December 31, 2024

Study information

• Verified date: March 2024
• Source: Unidade Local De Saúde Do Norte Alentejano
• Contact: Beatriz Mourato, MD
• Phone: 00351910311213
• Email: 2091[@]ulsna.min-saude.pt
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Endoscopic screening of gastric cancer combined with screening colonoscopy

Description:

A local prospective cohort study will be developed to test the theoretical cost-effectiveness model of endoscopic gastric cancer screening, at the same time as colorectal cancer screening colonoscopy in an European intermediate-risk country The investigators propose that patients who have a screening colonoscopy scheduled undergo simultaneously screening upper endoscopy with biopsies. This study is conducted by 3 investigators in 2 Hospitals of Unidade Local de Saúde do Norte Alentejano, em Portugal.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 139
• Est. completion date: December 31, 2024
• Est. primary completion date: July 31, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 40 Years and older

Eligibility

Inclusion Criteria:

• people who agree to undergo endoscopic screening for gastric cancer;
• people who undergo screening colonoscopy

Exclusion Criteria:

• Exams without biopsies

Related Conditions & MeSH terms

• Gastric Cancer
• Stomach Neoplasms

Intervention

Diagnostic Test:
• Screening endoscopy
We perform upper endoscopy, when the patient authorizes it, during their screening colonoscopy

Locations

Country	Name	City	State
Portugal	ULSNA	Portalegre

Sponsors (2)

Lead Sponsor	Collaborator
Unidade Local De Saúde Do Norte Alentejano	NOVA Medical School

Country where clinical trial is conducted

Portugal, 

References & Publications (15)

Almeida N, Romaozinho JM, Donato MM, Luxo C, Cardoso O, Cipriano MA, Marinho C, Fernandes A, Calhau C, Sofia C. Helicobacter pylori antimicrobial resistance rates in the central region of Portugal. Clin Microbiol Infect. 2014 Nov;20(11):1127-33. doi: 10.1111/1469-0691.12701. Epub 2014 Jul 12. — View Citation

Areia M, Carvalho R, Cadime AT, Rocha Goncalves F, Dinis-Ribeiro M. Screening for gastric cancer and surveillance of premalignant lesions: a systematic review of cost-effectiveness studies. Helicobacter. 2013 Oct;18(5):325-37. doi: 10.1111/hel.12050. Epub 2013 Apr 9. — View Citation

Areia M, Spaander MC, Kuipers EJ, Dinis-Ribeiro M. Endoscopic screening for gastric cancer: A cost-utility analysis for countries with an intermediate gastric cancer risk. United European Gastroenterol J. 2018 Mar;6(2):192-202. doi: 10.1177/2050640617722902. Epub 2017 Jul 18. — View Citation

Burra P, Bretthauer M, Buti Ferret M, Dugic A, Fracasso P, Leja M, Matysiak Budnik T, Michl P, Ricciardiello L, Seufferlein T, van Leerdam M, Botos A. Digestive cancer screening across Europe. United European Gastroenterol J. 2022 May;10(4):435-437. doi: 10.1002/ueg2.12230. Epub 2022 Apr 26. No abstract available. — View Citation

Faria L, Silva JC, Rodriguez-Carrasco M, Pimentel-Nunes P, Dinis-Ribeiro M, Libanio D. Gastric cancer screening: a systematic review and meta-analysis. Scand J Gastroenterol. 2022 Oct;57(10):1178-1188. doi: 10.1080/00365521.2022.2068966. Epub 2022 May 9. — View Citation

He J, Hu W, Ouyang Q, Zhang S, He L, Chen W, Li X, Hu C. Helicobacter pylori infection induces stem cell-like properties in Correa cascade of gastric cancer. Cancer Lett. 2022 Aug 28;542:215764. doi: 10.1016/j.canlet.2022.215764. Epub 2022 May 31. — View Citation

Ishii N, Shiratori Y, Ishikane M, Omata F. Population effectiveness of endoscopy screening for mortality reduction in gastric cancer. DEN Open. 2023 Sep 19;4(1):e296. doi: 10.1002/deo2.296. eCollection 2024 Apr. — View Citation

Januszewicz W, Turkot MH, Malfertheiner P, Regula J. A Global Perspective on Gastric Cancer Screening: Which Concepts Are Feasible, and When? Cancers (Basel). 2023 Jan 21;15(3):664. doi: 10.3390/cancers15030664. — View Citation

Kim GH, Liang PS, Bang SJ, Hwang JH. Screening and surveillance for gastric cancer in the United States: Is it needed? Gastrointest Endosc. 2016 Jul;84(1):18-28. doi: 10.1016/j.gie.2016.02.028. Epub 2016 Mar 3. — View Citation

Kim H, Hwang Y, Sung H, Jang J, Ahn C, Kim SG, Yoo KY, Park SK. Effectiveness of Gastric Cancer Screening on Gastric Cancer Incidence and Mortality in a Community-Based Prospective Cohort. Cancer Res Treat. 2018 Apr;50(2):582-589. doi: 10.4143/crt.2017.048. Epub 2017 Jun 9. — View Citation

Lansdorp-Vogelaar I, Meester RGS, Laszkowska M, Escudero FA, Ward ZJ, Yeh JM. Cost-effectiveness of prevention and early detection of gastric cancer in Western countries. Best Pract Res Clin Gastroenterol. 2021 Mar-Apr;50-51:101735. doi: 10.1016/j.bpg.2021.101735. Epub 2021 Feb 22. — View Citation

Leja M, You W, Camargo MC, Saito H. Implementation of gastric cancer screening - the global experience. Best Pract Res Clin Gastroenterol. 2014 Dec;28(6):1093-106. doi: 10.1016/j.bpg.2014.09.005. Epub 2014 Sep 28. — View Citation

Lopez MJ, Carbajal J, Alfaro AL, Saravia LG, Zanabria D, Araujo JM, Quispe L, Zevallos A, Buleje JL, Cho CE, Sarmiento M, Pinto JA, Fajardo W. Characteristics of gastric cancer around the world. Crit Rev Oncol Hematol. 2023 Jan;181:103841. doi: 10.1016/j.critrevonc.2022.103841. Epub 2022 Oct 11. — View Citation

Rawla P, Barsouk A. Epidemiology of gastric cancer: global trends, risk factors and prevention. Prz Gastroenterol. 2019;14(1):26-38. doi: 10.5114/pg.2018.80001. Epub 2018 Nov 28. — View Citation

Saftoiu A, Hassan C, Areia M, Bhutani MS, Bisschops R, Bories E, Cazacu IM, Dekker E, Deprez PH, Pereira SP, Senore C, Capocaccia R, Antonelli G, van Hooft J, Messmann H, Siersema PD, Dinis-Ribeiro M, Ponchon T. Role of gastrointestinal endoscopy in the screening of digestive tract cancers in Europe: European Society of Gastrointestinal Endoscopy (ESGE) Position Statement. Endoscopy. 2020 Apr;52(4):293-304. doi: 10.1055/a-1104-5245. Epub 2020 Feb 12. — View Citation

* Note: There are 15 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	number of gastric adenocarcinoma	number of gastric adenocarcinomas detected in patients undergoing opportunistic endoscopic screening, confirmed by histological examination of biopsies obtained during the screening endoscopic examination	1 month
Secondary	number of pre-malignant lesions	number of cases of intestinal metaplasia or atrophic gastritis detected in the histological examination of biopsies obtained during endoscopic screening	1 month
Secondary	Costs of screening endoscopy	costs in euros of each endoscopic examination in addition to the base cost of the scheduled colonoscopy screening	1 year
Secondary	Socio-demographic characteristics of population in screening program	Determine the correlation between the socio-demographic characteristics of patients and the detection of gastric cancer by opportunistic screening	1 month

External Links

•   Global Cancer Observatory
•   National Cancer Institute